DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 4/2/2026. As directed by the amendment: claim(s) 1, 11, and 17 have been amended, claim(s) 2 have been cancelled. Thus, claims 1 and 3-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 4/2/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the independent claims on page 6-10:
Applicant first argues that Amschler “does not disclose detecting a resonant condition based on measurements of the signal generator's voltages or currents. Rather, Amschler detects resonance, if at all, based on characteristics of the ultrasonic signals received (e.g., reflected waves) as processed by an ultrasonic receiver”. Applicant expands on this argument and alleges that Nishizu’s teachings do not cure this supposed deficiency of Amschler because “Nishizu's approach is tied to the electrical behavior of a speaker coil and the resonance of a gas- filled cavity, rather than to the excitation and detection of the medicament container's own resonance”.
Applicant’s arguments ignore the details of the specific embodiment of Amschler referenced by the examiner, the device 800, for disclosing certain claim limitations, rather applicant instead discusses the embodiment of device 700 which is not relied upon for in examiner’s preceding and present rejection. Thus applicant’s aforementioned arguments regarding Amschler are moot and irrelevant to examiner’s rejection as examiner’s rejection of the claims do not rely upon the argued embodiment.
Applicant’s arguments regarding Nishizu’s teachings, alleges that if Nishizu’s teachings pertain to the resonance of a cavity then such teachings are inapplicable to Amschler and incongruent with the excitation and detection of a medicament container’s resonance. However, examiner notes that in the presently amended claims, as well as the inventions of Amschler and Nishizu, the container comprises a cavity. In the case of the presently amended claims, this cavity is bound by the “an elongated body having a tubular shaped sidewall, an outlet at a distal end of the elongated body, and a bung arranged inside the elongated body and slidable along the tubular shaped sidewall”, or otherwise known as the elements of the claimed medicament container, and further this cavity is referred to as interior volume 109 in applicant’s disclosure. Further Amschler’s cavity is bound by its piston 820, the sidewalls (not enumerated) of cartridge 810, and the bottom 812. Thus, during the application and incorporation of Nishizu’s teachings into Amschler, the modified invention of elicits and detects a resonance of a medicament container in that the invention elicits and detects a resonance of the interior volume/cavity of the container.
Second applicant argues that examiner misconstrues the claim term “configured to” when discussing the prior art which discloses/teaches the claim limitations of “the one or more signals configured to excite one or more resonances of the medicament container”. Particularly arguing “the analysis must be grounded in the written description to determine whether the structure at issue is most naturally understood as designed or arranged to accomplish the specified objective. Mere capability is insufficient to satisfy a "configured to" limitation”.
Examiner notes that in applicant’s own disclosure, “the one or more signals configured to excite one or more resonances of the medicament container” are considered configured in this manner in that “the acoustic signal generator is configured to emit acoustic measurement signals of variable frequency the acoustic signal generator can be used to stimulate or to excite an acoustic resonance of the container”, see applicant’s page 14-15, and during the discussion of frequency sweeping on applicant’s page 31 “The frequency range between vmin and vmax is selected such that a resonance frequency or a higher harmonic of the resonance frequency of the container is larger than vmin but smaller than v'max. In this way it is guaranteed, that at least one resonance frequency or a higher harmonic thereof is located between v'min and vmax. During a variation of the frequency of the transducer 136 at a particular point of time the container 100 will be stimulated at a resonance frequency. If the momentary frequency of the transducer 136 matches the resonance frequency or a higher harmonic of the resonance frequency of the container 100 a well-defined". Thus, the claimed signal generator and the claimed one or more signals generated thereby can be considered configured to excite one or more resonances of the medicament container in that the generator can sweep the frequency of the signals over a spectrum encompassing the resonant frequency”. Thus, Amschler’s signal generator and the generated signals can be considered configured to perform this function in that the signal can be generated in a number of varying frequency bands, see Amschler’s paragraph 76, such that the claimed resonant frequency can exist within these varying bands.
Applicant further argues in this second argument that Nishizu does not cure this alleged deficiency because “Nishizu is limited to acoustically stimulating an empty or gaseous cavity located between static boundary walls. Nishizu does not excite a resonance of the medicament container itself, as required by the claims. Instead, Nishizu relies on the Helmholtz resonances of gaseous cavities rather than those of the container structure”, citing paragraph 10 -12 of Nishizu. Applicant argues “the claimed invention is directed to exciting and detecting resonances of the medicament container itself, including conditions in which the container' s volume and/or total weight change due to movement of the bung relative to the container body”, appearing to attempt to distinguish between a resonance of a cavity of the container and a resonance of the walls of the container. Applicant continues that Nishizu’s teachings cannot account for dynamical structural changes, such as a bung changing positions relative to a bottom of the medicament container.
Examiner first notes the preceding arguments which hold that Nishizu’s teaching provide a resonance of a cavity/internal volume of the container, and therein provide a resonance of the container. Applicant’s presently amended claims are not so specific as to delineate that the resonance produced is limited only to the wall(s) which bound the medicament container, however if they were amended in this regard they could distinguish from the prior art of record, however further search and consideration of such possible claim language would likely be required. In this regard examiner notes that applicant’s page 3 line 30-33, page 4 line 9-13, and page 12 line 28-32 appear to discuss certain elements like the disclosed sidewall and outlet having a resonating interaction with the measurement signal. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the invention accounting for dynamic structural changes, such as a movement of a bung and consequent change in internal volume) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). If applicant were to incorporate such functional configurations into the independent claims, such amended claims could distinguish from the prior art of record, however further search and consideration of such possible claim language would likely be required. In this regard examiner notes that applicant’s page 15 line 7-24, page 32 line 1-30, page 35 line 1 to page 36 line 18 discuss how differences in resonance frequency occur due to a change in the size of the interior volume and/or an indication of a change in longitudinal position of the bung and thus an amount of drug volume being dispensed from/filled into the container.
Accordingly, preceding rejection and the present rejection in view of applicant’s amendments stands in view of the prior art of record previously and presently presented.
Regarding applicant’s argument regarding dependent claims on page 10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner’s arguments above and examiner's rejection as necessitated by the amendment, below, detailing the reasons the prior art previously and presently relied upon disclose/teach the limitations of the presently amended claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-2, 4-6, 8, 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190054252 A1, henceforth written as Amschler, in view of US 20070193350 A1, henceforth written as Nishizu.
Regarding Claim 1
Amschler discloses:
An injection device comprising:
(medicine delivery device 800; fig 8)
a medicament container, the medicament container comprising an elongated body having a tubular shaped sidewall, an outlet at a distal end of the elongated body, and a bung arranged inside the elongated body and slidable along the tubular shaped sidewall;
(cartridge 810 having needle 840 and piston 820; fig 8; see examiner’s annotation of Amschler’s fig 8, denoting the claimed elongated body and tubular shaped sidewall)
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a signal generator configured transmit one or more signals towards the medicament container,
(paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8)
the one or more signals configured to excite one or more resonances of the medicament container;
Examiner notes claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function exciting one or more resonances in the medicament container. As disclosed by in paragraph 65-66 of Amschler, an emitted ultrasonic wave signal, such as the ultrasonic signal emitted in the embodiment of paragraph 72-77 and fig 8, can interfere with the reflected signal such an acoustic resonance is excited within the cavity of the container. Thus, the ultrasonic signal emitted by Amschler's transceiver 850 is functionally capable of exciting a resonance of cartridge 810.
a signal detector configured to measure [the one or more signals transmitted by] the signal generator while the signal generator transmits the one or more signals; and
(paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8)
a processor configured to determine one or more properties of the medicament container based on the measured one or more [signals transmitted by the signal generator] and
(paragraph 72-77; processing circuitry (not enumerated/illustrated) of the receiver of the ultrasonic transceiver 850 determines round trip delay/time of flight based on the detected and transmitted signals, therein a time varying voltage/current of electronic information representing the waveform emitted from transceiver 850's transmitter, which is leveraged to determine a length of the cavity, therein a property of, of cartridge 810)
wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on the bung of the medicament container.
(paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830")
Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current:
However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein:
the system determines one or more properties of the medicament container based on the measured one or more voltages or currents
(paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2, in order to advantageously arrive at an invention which applies a known technique of utilizing voltage measurements of transmitted signals to make determinations about an acoustic cavity’s properties based on those voltage measurements to a similar known device which relies on measuring signals from an ultrasonic transmitter to make a determination of cavity length, see MPEP 2143(i)(d).
Regarding claim 4, the modified device of Amschler in view of Nishizu discloses:
The injection device of claim 1, wherein the one or more properties include at least one of a size of an interior volume of the medicament container or a position of a bung within the medicament container.
Amschler: (paragraph 72-77; processing circuitry (not enumerated/illustrated) of ultrasonic transceiver 850 determines length of the cavity, therein a size of an interior volume and a relative position of piston820/shaft830 inside, of cartridge 810 based on the detected and transmitted signals)
Regarding Claim 5,
Amschler discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Amschler’s present embodiment is silent regarding:
The injection device of claim 4, wherein the processor is configured to determine the one or more properties based on – frequency -- of the measured one or more voltages or currents.
Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal have elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave.
However, the presently modified device of Amschler remains silent as to the exact processing which determines that the resonant condition has occurred based on the transmitted signal, and thus is silent regarding the processor configuration of the present claim.
Notably, Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein:
the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents.
(paragraph 28-29+98-100+110-111+143; the peak of the voltage signal from the signal generator, coil of speaker 2 along the frequency-voltage spectrum occurs at the resonant frequency of the acoustic system as the oscillation created by speaker 2)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d).
Regarding claim 6, the modified device of Amschler in view of Nishizu teaches:
The injection device of claim 5, wherein one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of one or more frequencies of the one or more resonances of the medicament container.
Examiner notes that in light of the modification made in claim 5 above, the frequency of the voltage peak detected by Nishizu's teachings is indicative of the Amschler's medicament container reaching a resonant state.
Regarding claim 8, the modified device of Amschler in view of Nishizu discloses:
The injection device of claim 1, wherein the signal detector is configured to measure the one or more voltages or currents of the signal generator at each frequency of the one or more signals while the signal generator transmits the one or more signals.
(Examiner notes in light of the combination of Amschler in view of Nishizu in claim 1 above, the receiver (not enumerated/illustrated) of ultrasonic transceiver 850 measures the voltages of the claimed signal generator relative to the frequency spectrum of the transmitted signal. Further consider paragraph 76 of Amschler notes that that the invention is operable with multiple frequency bands, therein the claimed signal detector is measures the voltage of the signal of the claimed signal generator at the frequency which the signal generator transmits the signal at)
Regarding Claim 11,
Amschler discloses:
A medicament container comprising:
(cartridge 810; fig 8)
an elongated body having a tubular shaped sidewall, an outlet at a distal end of the elongated body, and a bung arranged inside the elongated body and slidable along the tubular shaped sidewall;
(cartridge 810 having needle 840 and piston 820; fig 8; see examiner’s annotation of Amschler’s fig 8, denoting the claimed elongated body and tubular shaped sidewall)
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a signal generator configured transmit one or more signals towards the medicament container,
(paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8)
the one or more signals configured to excite one or more resonances of the medicament container; and
Examiner notes claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function exciting one or more resonances in the medicament container. As disclosed by in paragraph 65-66 of Amschler, an emitted ultrasonic wave signal, such as the ultrasonic signal emitted in the embodiment of paragraph 72-77 and fig 8, can interfere with the reflected signal such an acoustic resonance is excited within the cavity of the container. Thus, the ultrasonic signal emitted by Amschler's transceiver 850 is functionally capable of exciting a resonance of cartridge 810.
a signal detector configured to measure one or more [signals transmitted by] the signal generator while the signal generator transmits the one or more signals, --
(paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8)
--wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on the bung of the medicament container.
(paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830")
Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the measured one or more [signals] being indicative of one or more frequencies of the one or more resonances of the medicament container
Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal had elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave.
The modified device of Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current:
However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein:
the system determines one or more properties of the medicament container based on the measured one or more voltages or currents
(paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d).
Regarding claim 12, the modified device of Amschler in view of Nishizu discloses:
The medicament container of claim 11, further comprising a processor configured to determine one or more properties based on the measured one or more voltages or currents.
(Examiner notes in light of the combination of Amschler in view of Nishizu above that the processing circuitry (not enumerated/illustrated) of Amschler utilizes Nishizu’s teachings of measuring a voltage of the signal transmitted by the claimed signal generator to determine a resonance of the invention’s acoustic cavity based on this measured voltage signal)
Regarding claim 13, the modified device of Amschler in view of Nishizu discloses:
The medicament container of claim 12, wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on a bung of the medicament container.
Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830")
Regarding claim 14, the modified device of Amschler in view of Nishizu discloses:
The medicament container of claim 12, wherein the one or more properties include at least one of a size of an interior volume of the medicament container or a position of a bung within the medicament container.
Amschler: (paragraph 72-77; processing circuitry (not enumerated/illustrated) of ultrasonic transceiver 850 determines length of the cavity, therein a size of an interior volume and a relative position of piston820/shaft830 inside, of cartridge 810 based on the detected and transmitted signals)
Regarding Claim 15,
The modified device of Amschler discloses all of the elements of the current invention which the present claim is dependent upon, as described above. Notably, the presently modified device of Amschler remains silent as to the exact processing which determines that the resonant condition has occurred based on the transmitted signal, and thus, the modified device of Amschler is silent regarding:
The injection device of claim 12, wherein the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents.
Notably, Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein:
the processor is configured to determine the one or more properties based on one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents.
(paragraph 28-29+98-100+110-111+143; the peak of the voltage signal from the signal generator, coil of speaker 2, along the frequency-voltage spectrum occurs at the resonant frequency of the acoustic system created by speaker 2; fig 1+5)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d).
Regarding claim 16, the modified device of Amschler in view of Nishizu discloses:
The medicament container of claim 15, wherein one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of one or more frequencies of the one or more resonances of the medicament container.
Examiner notes that in light of the modification made in claim 15 above, the frequency of the voltage peak detected by Nishizu's teachings is indicative of the Amschler's medicament container reaching a resonant state.
Regarding Claim 17,
Amschler discloses:
A method comprising:
(invention of fig 8)
transmitting, by a signal generator, one or more signals towards
(paragraph 72-77; transmitter (not enumerated/illustrated) of ultrasonic transceiver 850; fig 8)
a medicament container
(cartridge 810; fig 8)
the medicament container comprising an elongated body having a tubular shaped sidewall, an outlet at a distal end of the elongated body, and a bung arranged inside the elongated body and slidable along the tubular shaped sidewall;--
(cartridge 810 having needle 840 and piston 820; fig 8; see examiner’s annotation of Amschler’s fig 8, denoting the claimed elongated body and tubular shaped sidewall)
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while the signal generator transmits the one or more signals, measuring, by a signal detector, [the one or more signal transmitted by] the signal generator; and
(paragraph 72-77; receiver (not enumerated/illustrated) of ultrasonic transceiver 850 receives the ultrasonic signal transmitted by the transmitter of transceiver 850 while the transmitter is emitting the signal; fig 8)
determining, by a processor, one or more properties of the medicament container based on the measured one or more [signals transmitted by the signal generator]
(paragraph 72-77; processing circuitry (not enumerated/illustrated) of the receiver of the ultrasonic transceiver 850 determines round trip delay/time of flight based on the detected and transmitted signals, therein a time varying voltage/current of electronic information representing the waveform emitted from transceiver 850's transmitter, which is leveraged to determine a length of the cavity, therein a property of, of cartridge 810)
wherein at least one of the signal generator, the signal detector, or the processor is disposed in or on the bung of the medicament container.
(paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830")
Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
transmitting -- one or more signals towards a medicament container to excite one or more resonances of the medicament container
Notably, Amschler teaches an alternative embodiment for determining a cavity’s length in paragraph 64-71 with a resonant frequency based measurement where upon detecting that the transmitted ultrasonic signal had elicited a resonant condition in the cavity, the “frequency of the transmitted ultrasonic signals at the resonant condition may then be used to determine the length of the resonant cavity”.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Amschler’s alternative means of determining a cavity’s length using a resonant frequency based measurement to Amschler’s disclosed method of operating its invention of fig 8, in order to advantageously arrive at an invention with multiple redundant means for determining a length of a cavity of a drug container and thus improve the reliability of the invention against failure modes limiting the efficacy of a single one of the measurement means, such as failure to receive/measure a reflected acoustic wave.
The modified device of Amschler discloses the elements of the present claim, as described above. Yet, its present embodiment is silent regarding the precise type of signal/unit of measurement measured by the signal detector and examined by the processor for determining a property of the medicament container being that of a voltage or current:
However Nishizu teaches a processing system of invention which determines a resonant frequency of an acoustic cavity system wherein:
the system determines one or more properties of the medicament container based on the measured one or more voltages or currents
(paragraph 28-29+98-100+110-111+143; the voltage signal from the signal generator, coil of speaker 2, is analyzed with respect to the frequency spectrum of the emitted signal to determine a resonant frequency of the acoustic system)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Nishizu’s teachings of analyzing the voltage signal from its transmitter for a peak value to determine when an acoustic system has reached acoustic resonance to the modified device of Amschler, by replacing Amschler’s transmitter with Nishizu’s speaker 2 such that Amschler’s transceiver 850’s processing circuitry can incorporate the processing teaching of Nishizu to measure the voltage signal from Nishizu’s speaker 2 and determine when the emitted signal has moved Amschler’s device 800 into a resonant condition, in order to advantageously arrive at an invention which applies a known technique of identifying resonant conditions based on a transmitted signal to a similar known device which relies on detecting that resonant condition to make a determination of cavity length, see MPEP 2143(i)(d).
Regarding Claim 18, The modified method of Amschler in view of Nishizu teaches:
The method of claim 17, wherein the one or more voltages or currents are measured at each frequency of the one or more signals.
Examiner notes that in light of the combination of Amschler in view of Nishizu made in claim 17 above, the signal detector and processing circuitry of Amschler performs Nishizu’s teachings in paragraph 28-29+98-100+110-111+143 and fig 5, of determining a resonant frequency based on the voltage-frequency spectrum of the signal, thus measuring the voltage of the signal at each frequency which the one or more signals are emitted at.
Regarding Claim 19, The modified method of Amschler in view of Nishizu teaches:
The method of claim 17, wherein determining the one or more properties comprises determining one or more positive or negative frequency-dependent peaks of the measured one or more voltages or currents.
Examiner notes that in light of the combination of Amschler in view of Nishizu made in claim 17 above, the signal detector and processing circuitry of Amschler performs Nishizu’s teachings in paragraph 28-29+98-100+110-111+143 and fig 5, of determining a resonant frequency based on the voltage-frequency spectrum, and particularly the frequency dependent peak of the signal, thus measuring the voltage of the signal at each frequency which the one or more signals are emitted at.
Regarding claim 20, the modified method of Amschler in view of Nishizu discloses:
The method of claim 19, wherein determining the one or more properties comprises: determining one or more frequencies of the positive or negative frequency-dependent peaks; and determining the one or more properties based on the one or more frequencies of the positive or negative frequency-dependent peaks.
Examiner notes in view of the combination made in claim 19 above, the step of determining the property of the medicament container involves identifying the frequency by where the voltage of the signal from the signal generator is at a positive/negative peak.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claims above, in view of US 10869967 B2 henceforth written as Sleicher.
Regarding Claim 3,
The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The injection device of claim 1, wherein the signal generator, the signal detector -- are disposed in or on a bung of the medicament container.
Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830")
However, the modified device of Amschler in view of Nishizu is silent regarding:
wherein the processor [is] disposed in or on a bung of the medicament container.
However, Sleicher teaches a drug delivery device with a sensor system embedded in its bung, wherein in fig 7 it is illustrated and in col 8 line 34 to col 9 line 51 it is detailed that the sensitive electronics (i.e. transducer, sensor, power, processing circuitry, etc.) are embedded within stopper 700 and surrounded by a material which undergoes a phase change proximate to the temperature which the device is sterilized at in order to protect the electronics from excess heat energy present in the sterilization process which could overheat such sensitive electronics.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Sleicher’s teachings of disposing its sensitive electronics within its stopper of a specific material, to the sensitive electronics disclosed by the modified device of Amschler in view of Nishizu, thus disposing the claimed signal generator, claimed signal detector, and claimed processor within Amschler’s bung and forming Amschler’s bung from Sliecher’s phase change material, in order to advantageously arrive at an invention which protects its sensitive electronics from the sterilization process imposed on medical devices, see col 9 line 7-23 of Sleicher.
Regarding Claim 9,
The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The injection device of claim 1, further comprising a circuit board disposed in or on a bung of the medicament container, the circuit board comprising -- the signal generator, and the signal detector.
Amschler: (paragraph 75, "ultrasonic transceiver 850 located in dispensing piston 820 or shaft 830"; the circuitry which enjoins the electronic elements of the ultrasonic transceiver 850, such as its transmitter and receiver, is considered the claimed circuit board because of the manner by which it connects electronic elements together to communicate signals therebetween)
However, the modified device of Amschler in view of Nishizu is silent regarding:
a circuit board disposed in or on a bung of the medicament container, the circuit board comprising a processor
However, Sleicher teaches a drug delivery device with a sensor system embedded in its bung, wherein in fig 7 it is illustrated and in col 8 line 34 to col 9 line 51 it is detailed that the sensitive electronics (i.e. transducer, sensor, power, processing circuitry, etc.) are embedded within stopper 700 and surrounded by a material which undergoes a phase change proximate to the temperature which the device is sterilized at in order to protect the electronics from excess heat energy present in the sterilization process which could overheat such sensitive electronics.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Sleicher’s teachings of disposing its sensitive electronics within its stopper of a specific material, to the sensitive electronics disclosed by the modified device of Amschler in view of Nishizu, thus disposing the Amschler’s claimed circuit board and thus also its claimed signal generator, claimed signal detector, and claimed processor within Amschler’s bung and forming Amschler’s bung from Sliecher’s phase change material, in order to advantageously arrive at an invention which protects its sensitive electronics from the sterilization process imposed on medical devices, see col 9 line 7-23 of Sleicher.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claim 6 above, in view of US 5780743 A, henceforth written as Morgan.
Regarding Claim 7,
The modified device of over Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The injection device of claim 6, wherein a -- frequency of the one or more frequencies of the one or more positive or negative frequency-dependent peaks is indicative of a [harmonic and ] fundamental resonance frequency of the medicament container
Examiner notes that harmonic frequencies of a system are themselves indicative of the fundamental resonance frequency of that system as they are inherently a multiple of that fundamental frequency. Similarly, any harmonic resonant frequency is a harmonic multiple of the fundamental resonance frequency. Therein, the frequency measured by the processing teachings of Nishizu applied to the modified device of Amschler is indicative of both the harmonic resonance frequency and a fundamental frequency.
However, the modified device of Amschler in view of Nishizu is silent regarding the processor measuring multiple harmonic frequencies to identify multiple positive or negative frequency-dependent peaks indicative of harmonic resonance and fundamental resonance frequencies of the one or more resonances of the medicament container.
However, Morgan teaches an invention for determining a resonance condition in a fluid filled cylinder wherein in col 3 line 60 to col 4 line 48 and figure 3 it is taught that when the invention identifies multiple higher order harmonic frequencies, the first order harmonic frequency aka the fundamental resonant frequency may be identified and locked on to accurately calculate a resonant frequency by limiting the noise which is amplified in higher order resonant frequencies.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Morgan’s teachings of identifying multiple higher order harmonic frequencies to hone in on a base fundamental frequency for determining a resonant frequency of the system to the processing system disclosure of the modified device of Amschler in view of Nishizu, in order to advantageously arrive at an invention which “permits calculations that yield highly accurate resonance frequency values”, see col 4 line 31-32 of Morgan.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Amschler in view of Nishizu, as applied to claims above, in view of US 4285053 A, henceforth written as Kren.
Regarding Claim 10,
The modified device of Amschler in view of Nishizu discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Amschler in view of Nishizu is silent regarding:
The injection device of claim 1, wherein the signal detector comprises an impedance measurement circuit comprising a diode, a capacitor, and an analog-to-digital converter electrically connected to a node between the diode and the capacitor.
Examiner notes that the present embodiment of Amschler relies upon detecting a difference in a phase shift of an ultrasonic wave to determine time of flight of a transmitted acoustic wave to determine a length of its acoustic cavity, see paragraph 72-77, however, it does not recite the exact processing technique/structure which determines this phase shift to perform the consequent cavity length determination.
However, Kren teaches a distance gauge which relies upon phase shifts in transmitted/received acoustic waves to determine a distance which great accuracy
wherein the signal detector comprises an impedance measurement circuit
(circuit (not enumerated) of fig 3, excluding oscillator 25 and wire 15, detects signals from the microphone 33 via the circuit’s wires 35 and from oscillator 25 via the circuit’s wires 36, and thus may be equated to a signal detector which has circuitry to measure/record the effects of the acoustic impedance of the system, therein an impedance measurement circuit; fig 1-3)
comprising a diode,
(diode 47; fig 3)
a capacitor, and
(capacitor 57; fig 3)
an analog-to-digital converter electrically connected to a node between the diode and the capacitor
(analog-to-digital converter 63; fig 3; see examiner’s annotation of Kren’s fig 3 denoting the node between the diode 47 and capacitor 57 which converter 63 is electrically connected to)
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468
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Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to import the signal processing means and structure taught by Kren into the signal detector and processing circuitry disclosed by Amschler, as Amschler is silent regarding the exact signal processing means it relies upon to measure its acoustic signal’s phase shift in determining its cavity length/distance and applying the known technique of Kren would advantageously provide means for measuring this phase shift with micron level accuracy, see col 1 line 51 to col 2 line 2.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the independent claims, as they pertain to sensory systems disposed in fluid ejection systems determining certain system characteristics by utilizing resonant conditions/signals:
US 20100288036 A1
US 20150174330 A1
US 10413676 B1
US 5608332 A
US 5780743 A
US 20160258803 A1
US 6318180 B1
EP 1319846 A1
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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